POLY-PRED® Liquifilm® sterile ophthalmic suspension is a topical anti-inflammatory/anti-infective combination product for ophthalmic use.

Chemical Name:   Prednisolone acetate: 11(beta), 17, 21-Trihydroxypregna-1, 4-diene-3, 20-dione 21-acetate.

Neomycin sulfate is the sulfate salt of neomycin B and neomycin C which are produced by the growth of Streptomyces fradiae (Fam. Streptomycetaceae ). It has a potency equivalent to not less than 600 micrograms per milligram of neomycin base, calculated on an anhydrous basis.

Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and polymyxin B 2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae ). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis.

Contains:   Actives: prednisolone acetate (microfine suspension) 0.5%, neomycin sulfate equivalent to 0.35% neomycin base, polymyxin B sulfate 10,000 units/mL. Preservative: thimerosal 0.001%. Inactives: Liquifilm® (polyvinyl alcohol) 1.4%; polysorbate 80; propylene glycol; sodium acetate; and purified water.

Clinical Pharmacology:   Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body' defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

The anti-infective components in POLY-PRED® are included to provide action against specific organisms susceptible to them. Neomycin sulfate and polymyxin B sulfate are considered active against the following microorganisms: Staphylococcus aureus; Escherichia coli; Haemophilus influenzae; Klebsiella/Enterobacter species Neisseria species; and Pseudomonas aeruginosa.

When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

and Usage:   A steroid/antiinfective combination is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus; Escherichia coli; Haemophilus influenzae; Klebsiella/Enterobacter species Neisseria species; and Pseudomonas aeruginosa.

The product does not provide adequate coverage against: Serratia marcescens; Streptococci, including Streptococcus pneumoniae.

Contraindications:   Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of the ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.

:   Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Employment of a steroid medication in the treatment of herpes simplex requires great caution.

There exists a potential for neomycin sulfate to cause cutaneous sensitization. The exact incidence of this reaction is unknown.

Precautions:   The initial prescription and renewal of the medication order beyond 20 milliliters should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.

Adverse Reactions:   Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection: development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs.

Dosage and Administration:   TO TREAT THE EYE: 1 or 2 drops every 3 or 4 hours, or more frequently as required. Acute infections may require administration every 30 minutes, with frequency of administration reduced as the infection is brought under control. TO TREAT THE LIDS: Instill 1 or 2 drops in the eye every 3 to 4 hours, close the eye and rub the excess on the lids and lid margins.

Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in the Precautions section above.

How Supplied:   POLY-PRED® Liquifilm® sterile ophthalmic suspension is supplied in plastic dropper bottles in the following sizes:

 5 mL--NDC 0023-0028-05

10 mL--NDC 0023-0028-10

Note:   Store at or below 25°C (77°F). Protect from freezing. Shake well before using.

Rx only